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Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.

It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy [ Time Frame: baseline ]

It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy [ Time Frame: 3 months ]

It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy [ Time Frame: 9 months ]

Secondary Outcome Measures:

blood draw (20mL) [ Time Frame: on day of EMBx ]

A combination of quantitative real time PCR, immunohistochemistry, and Western Blot techniques will be utilized for studying endometrial markers of receptivity in the endometrial tissue [ Time Frame: 9 months ]

Subjects provided with a 10 day supply of vaginal progesterone and EMBx will be scheduled between days 6-8 of progesterone use.

Visit 2: Baseline

Urine pregnancy test

Endometrium thickness will be measured via transvaginal ultrasound

EMBx: sample of endometrial tissue will be sent for histopathology to rule out endometrial hyperplasia or cancer

20cc blood

Metformin prescription and dispensing will be as per clinical care.

Women will be advised to use barrier method of contraception (ie; condoms, contraceptive jellies or foam, sponge, diaphragm, or cervical cap) for the duration of the study.

Visits 3 and 5 (Weeks 8-10 and 30-34, respectively)

Urine pregnancy test

A 10 day course of vaginal progesterone to allow scheduling of EMBx's time points specified under visit 1

Visits 4 and 6 (Weeks 12 ± 1 week and 36 ± 1 week respectively)

- The procedure specified for baseline (Visit 2) will be repeated.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 42 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Women will be recruited from the multi-physician Yale Reproductive Endocrinology clinical practice and Yale Fertility Center. Metformin is a routinely employed therapeutic strategy utilized for managing PCOS by practitioners at YFC. Almost 1/3 of the patients with PCOS are not interested in pursuing fertility in the immediate future and it is these patients who will be offered participation in the trial.

Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months

Able to provide signed informed consent

Able to comply with study requirements

Willing to delay the start of clinically prescribed metformin treatment

Exclusion Criteria:

Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)

Current use of hormonal contraceptives

Seeking pregnancy; use of fertility drugs within 6 months of study

Current or recent (within 3 months) use of metformin

Ingestion of any investigational drug within two months prior to study onset

Evidence of endometrial hyperplasia or cancer upon baseline EMBx

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070160

Locations

United States, Connecticut

Yale-New Haven Hospital Women's Center

New Haven, Connecticut, United States, 06520-8063

Sponsors and Collaborators

Yale University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)